Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients.

What are the concerns?

Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” for vision. That case appears settled.

SEC filings by U.S. Stem Cell also disclosed another suit against them involving a different plaintiff, Patsy Bade. Note that U.S. Stem Cell Inc. used to be called Bioheart, Inc., has a subsidiary called U.S. Stem Cell Clinic LLC, and that Kristin Comella is a leader of U.S. Stem Cell.

From the SEC Filing by U.S. Stem Cell:

“On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D. During the six months ended June 30, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company.”

I’ve been wondering about the circumstances of Bade’s suit, which like the Noble case was mentioned as being in Broward County, but the Bade case didn’t appear on their county court website. As a result, I did other research as time permitted.

A court search in the adjacent Miami-Dade County using the search term “Bioheart”, again the old name of U.S. Stem Cell, Inc., revealed that Bade had filed a lawsuit in that county against some of the same parties involved in the Noble case.

Bade has apparently settled with US Stem Cell, Inc., but as best as I could tell as a non-attorney she has not so far settled with Dr. Shareen Greenbaum and her place of business the Hollywood Eye Institute.

What did Bade claim had happened?

She alleged that a stem cell treatment she received caused her to go blind, an allegation that remains unconfirmed to my knowledge. This case raises pressing questions though. I recommend reading the amended complaint document if you want to at least try to learn more. It is publicly available on the court site and I have posted it here. U.S. Stem Cell, Inc. and its leader Kristin Comella are mentioned extensively in the amended complaint.

Comella made a public comment at the second FDA stem cell meeting in September on the FDA stem cell draft guidances, speaking about the beneficial use of stem cells and for less government oversight of stem cells:

“The government should not regulate our bodies. I’m Kristin Comella, and I will always stand up for patient rights,” said Kristin Comella, chief science officer for Florida-based U.S. Stem Cell, another prominent stem cell treatment provider.”

The amended complaint in the Bade suit lists many allegations including some listed below verbatim, but they are not verified so be cautious in interpretation:

“U.S. Stem Cell, Inc. was operating a business for profit, under the guise of a clinical research trial.”

“Ms. Comella is not a physician, and, at all times relevant to this lawsuit, she did not have any degree in medicine or cell biology. Nonetheless, Ms. Comella touted herself as an expert in adipose stem cell research and actively participated in U.S. Stem Cell, lnc.’s stem cell procedures.”

“Mr. Perez, who was supposedly trained as a doctor in Cuba, was routinely introduced as a physician to prospective U.S. Stem Cell Clinic patients.”

“Dr. Greenbaum had little or no experience in conducting medical research or clinical trials and had no experience with stem cells. Ms. Comella knew this, but advised that experience was not necessary.”

“Dr. Greenbaum did nothing to communicate her concerns about the clinical trial, nor did she do anything to dissuade Ms. Bade from going forward with this procedure.”

“Following the surgery, Ms. Bade’s vision worsened drastically and she is now legally blind.”

What’s actually going on here?

Things are not yet entirely clear.

The amended complaint is all we have to go on so far though as the people involved in the case aren’t opening up about it. The main attorney listed in that document as representing Bade, Andrew Yaffa, said that he was unable to comment, and my emails (one 2 months ago based on the FDA meeting and another 2 weeks ago based on the Bade case) to Comella with a few questions have not been answered. If anyone else knows of similar cases or more facts on these cases, the community would benefit from knowing about them.

Comella did earlier give an interviewto NPR where she reportedly acknowledged two negative eye outcomes and said U.S. Stem Cell was no longer doing vision treatments:

“Comella acknowledges that two of her clinic’s patients suffered detached retinas after getting stem cells injected into their eyes. As a result, the clinic has stopped treating eye conditions. But otherwise, Comella says, the clinic has had no serious problems. It offers stem cell treatments for a host of conditions including diabetes, spinal cord injuries and congestive heart failure.”

I’ll leave it for readers to go through the amended complaint document and draw their own conclusions, but the claims listed there in my opinion raise serious questions and the stem cell community needs to learn more about this situation to better understand what happened and help patients avoid negative outcomes in the future.

Other cases of alleged blindness or vision problems caused by clinics

With Noble also alleging a similar outcome as Bade, and Dr. Thomas Albini’s presentation at the first of two recent FDA meetings on stem cells mentioning three women blinded by a business in Florida, it is reasonable to ask, “were Bade and Noble two of the three women that Dr. Albini was alluding to?” I emailed Dr. Albini about two weeks ago asking for clarity, but he has not replied so far so I’m not sure. Unless I missed it, Albini did not mention the business(es) involved by name in his talk at the FDA meeting.

I also got to wondering about the identity of the third woman who was also allegedly blinded according to Albini and where she got stem cells. I couldn’t find any information on that situation. In addition, it was reported that a man at the second FDA stem cell meeting had a sign alleging that he had been blinded by a stem cell clinic involved in the SCOTS study, a different clinical experiment using stem cells for vision loss. Here is a recent update I did on the SCOTS trial and the patient’s allegations.

Dr. Albini and colleagues further published a case reportpaper in June on a man who had retinal detachment apparently caused by a stem cell transplant, but it’s not clear what the circumstances were of that case or if there are any link to those cases mentioned earlier in this post.

What happens next?

We shouldn’t let this concerning situation with clinics detract from the rigorous and exciting research ongoing in bona fide FDA-approved stem cell clinical trials for vision loss, but we also cannot ignore the potentially extremely serious alleged issues with vision in the stem cell clinic arena either. The FDA already should be actively looking into these situations and importantly let the public know quickly what is going on, but it’s unclear whether they are doing or will do anything. Importantly, in the interview I did with Comella last year hereshe said that the FDA had visited her company in December 2014, but apparently did not take any action.

Stay tuned for more developments in this area.

Note: neither U.S. Stem Cell, Inc. and U.S. Stem Cell Clinic nor the individuals/other businesses mentioned in the lawsuit or in the amended complaint in the settled case have been found liable for anything that was alleged, the allegations remain unconfirmed, and part of this case is to my knowledge still pending.

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